CN102858244A

CN102858244A - Lancet magazine and method for the production thereof

Info

Publication number: CN102858244A
Application number: CN201180022518XA
Authority: CN
Inventors: H.哈蒂希
Original assignee: F Hoffmann La Roche AG
Current assignee: F Hoffmann La Roche AG
Priority date: 2010-05-06
Filing date: 2011-04-13
Publication date: 2013-01-02
Anticipated expiration: 2031-04-13
Also published as: EP2384699A1; WO2011137966A1; US10524709B2; EP2384699B1; US20130066171A1; HK1176538A1; CN102858244B

Abstract

The invention relates to a lancet magazine comprising a housing (1) and multiple lancets (2), each of which is enclosed in a sterile chamber of the housing (1). Each of the chambers has a piercing opening (4) that is sealed with a foil. According to the invention, the lancets (2) have a sample receiving device (3) for receiving bodily fluid. Each of the chambers has another opening (6) which is sealed with a gas- and liquid-permeable membrane (8) that has a lower face facing the lancet (2) for receiving bodily fluid from the sample receiving device (3) and an upper face for transferring bodily fluid to a test field (7) that lies on the membrane (8). The invention further relates to a method for producing a lancet magazine and to the use of a membrane for transporting a bodily fluid sample from a lancet on one face of the membrane to a test field on the other face of the membrane.

Description

Pricker casket and for the manufacture of the method for pricker casket

The present invention relates to a kind of pricker casket with feature indicated in the preamble of claim 1.Such pricker casket has a housing and many root thorns pin, and described pricker is enclosed in respectively in the chamber of sterilizing of described housing, and wherein said chamber has respectively one and utilizes the puncture orifice of sealing such as the thin film of being made by plastics, metal or paper.Such pricker casket is open such as obtaining from EP 0 951 939 B1.

For known pricker casket, described pricker is arranged in the housing cavity with desiccant, and the opening of described housing cavity utilizes thin film to seal in the mode of moisture seal.Pricker is sterilized by strong radiation effects in such casket, perhaps joins in the described casket under the condition of sterilization with very large expense, and subsequently described pricker casket is closed.

Need the pricker casket for the puncture instrument, utilize described puncture instrument to obtain body fluid samples, normally the liquid of blood and/or interstice is used for material concentration to be tested is measured.Such puncture instrument and associated pricker casket are such as being that the diabetes patient is required, and the diabetes patient must check its blood sugar level in one day for several times.

The pricker casket comprises respectively many root thorns pin in the mode through sterilization wrap, and described pricker can successively be used with the puncture instrument.The pricker casket can be realized higher user comfortableness, because it utilizes simple handle to be encased in the thorn needle apparatus, and only just must be changed after being used all being included in wherein pricker.

Except the simple pricker for generation of puncture wound only, also know have the sample holding device, such as the pricker of capillary channel.Such pricker can be realized extra high user comfortableness, because do not need user to carry out independent operation to admit sample.In the time of in thrusting patient's body, such pricker itself is admitted body fluid samples, then can test to described body fluid samples.

Task of the present invention is, a kind of method is shown, and how can reduce for the manufacture of the cost that has therein through the pricker casket of the pricker of sterilization wrap.In addition, by the present invention, should be able to more easily admit and check body fluid samples.

This task has the pricker casket of feature illustrated in claim 1 and is resolved by the described method of claim 13 by a kind of by a kind of.Favourable improvement project of the present invention is the theme of dependent claims.

Have been found that within the scope of the invention for the packing that does not need moisture seal the depositing of the sterilization of pricker in casket.Pricker by pricker casket of the present invention is arranged in in ventilative and the chamber that the diaphragm of liquid seals thoroughly.Although under production, storage and service condition, prevent the intrusion of pathogen by the diaphragm of pricker casket of the present invention, allow sterilization usefulness gas, see through such as water vapour and/or the oxirane of heat.

The feature of production, storage and service condition is usually, and described diaphragm is not until be exposed among the liquid before obtaining body fluid samples, and after sterilization, because the less space of casket chamber and only being exposed among the less air-flow.Guarantee thus, even microgranule, can separate reliably such as the microorganism less than the diaphragm hole of maximum.Empirical equation as being used for microgranule is separated from air-flow slowly goes for usually: the microgranule that only has than 1/10th of conclusive pore diameter little diameters can pass described diaphragm.

Described hole has formed the passage that passes described diaphragm and stretch.The relevant pore diameter of described diaphragm is determined by the channel diameter in its narrowest place at this.The sort of passage that has maximum diameter at its narrowest place has been determined the permeability of described diaphragm.This diameter is described relevant pore diameter.

Preferably, the described diaphragm that uses by the present invention have coherent, have and be not more than 5 μ m, particularly preferably be not more than the hole of the associated diameters of 2 μ m.Such diaphragm can stop the microgranule of the size with 0.5 μ m or 0.2 μ m thus.Microorganism is usually larger, and therefore can be stoped by such diaphragm.Interrupted diaphragm can have in a side of its thick hole absolute larger, but the hole that narrows down towards a side of thin hole.For interrupted diaphragm, therefore the associated diameters of described hole for linking up is the pore diameter of a side of described pinhole.

The pricker casket that seals for the mode with moisture seal, can only be undertaken by radiation with huge expense for the sterilization that is included in pricker wherein, then can originally sterilize with remarkable lower one-tenth according to the pricker in the pricker casket of the present invention, method is that the gas with sterilization usefulness passes described diaphragm and joins in the described casket chamber.This can enough small expenses carry out, and is that described pricker casket exposes 20 minutes in the water vapour of 121 ℃ heat such as method.

Ventilative material is such as being made by fibrous material.Especially the adhesive-bonded fabric that is made of plastic optical fibre is suitable.But the diaphragm for ventilative also can use other mushy material, diaphragm or the similar material made such as the cellulated foamed materials of opening, according to the inversion of phases method.Hydrophilic diaphragm is preferred.

Pricker according to casket of the present invention has the sample holding device, such as one or more of passages for admitting body fluid samples.Such passage preferable configuration is groove or rill, but such as also can being the slit.Such sample holding device is full of body fluid by capillary force when pricker penetrates in the bodily tissue.

Surprisingly, the sample that can realize when the geometry of sample holding device is identical according to the pricker of pricker casket of the present invention admits effect than much better with the pricker in the mode of the moisture seal casket that seal, that sterilize by radiation effects.This is owing to following situation, namely when carrying out disinfection, the radiation by high energy in the plastics of casket housing, produces atomic group, and discharge low molecular chemical compound, described low molecular chemical compound can change gas phase into, and can be on the surface of pricker in the process of storage time separate in other words and be deposited.Deposit seems these educts in other words that the surface to pricker has hydrophobic effect, and therefore so that sample is admitted difficult.And according to the sterilization that is used for of the pricker of pricker casket of the present invention gas, especially water vapour by sterilization usefulness, in contrast, by pricker casket of the present invention, the surface of pricker then is not subject to bad impact for described.

After sterilization, the test section that will have for the testing reagent that body fluid samples is tested is applied to described ventilative diaphragm.Suitable testing reagent is commercially known in the commonly used calibration tape, such as being for photometering ground or electrochemically to glucose or other calibration tape measured of the concentration of significant material to be tested medically.Owing to just after sterilization, just settling the test section by pricker casket of the present invention, got rid of the danger that the testing reagent of sensitivity is produced bad impact by disinfecting process.

Described ventilative diaphragm can not only be used as in this way the sterilization barrier layer that stops pathogen to be invaded, and be used for body fluid samples is handed to described test section from pricker for by casket of the present invention.That is to say, because diaphragm that will breathe freely and thoroughly liquid is for sealing chamber opening, so the body fluid samples of being admitted by the sample holding device of pricker can be handed to described test section.Enough is that described pricker or its sample holding device are contacted with the medial surface of diaphragm for this reason.Described body fluid samples then can pass described diaphragm by capillary force and flow to described test section.

In order to have the upper side that is applied to described diaphragm for the test section of the testing reagent that body fluid samples is tested, different feasible programs is arranged.Such as described test section being configured on the carrier thin film, described carrier thin film is put on the described diaphragm, so that described testing reagent is arranged between described carrier thin film and the described ventilative diaphragm.Another kind of scheme is, testing reagent directly is coated onto on the surface of described diaphragm as mastic, and constructs the test section at the upper side of described diaphragm like this.Described testing reagent can be used as unique have the layer of defined composition and exists, and perhaps also can be used as a plurality of at the distinguishing and layer that replenishes each other on function and existing each other aspect its corresponding composition.Layer such as testing reagent can consist of the reflecting layer, and the layer that is in above it then demonstrates the variable color situation that depends on concentration.

For pressing casket of the present invention, the sealing of puncture orifice is the worse for wear when puncture, and as replenishing of described puncture orifice, described chamber has another and uses opening ventilative and that diaphragm saturating liquid seals, and this opening is fulfiled several functions.Described diaphragm can allow the gas of sterilization usefulness be squeezed in the described chamber in order to pricker is carried out disinfection, then as the sterilization barrier layer, be used for preventing that pathogen from invading described chamber, and after puncture, the sample holding device of the pricker of body fluid samples on the side of described diaphragm flowed to test section on the opposite side of described diaphragm.That is to say, described diaphragm have towards pricker, be used for admitting the downside of body fluid and being used for body fluid handed to the upper side that is in the test section on this diaphragm from the sample holding device.

Preferred each casket chamber also has insert port extraly, and the sealing of described insert port is worn out for the triggering piercing process is punctured instrument.But puncture orifice and insert port also can be merged into a unique opening, and this opening then is called puncture orifice for simplicity and equally.

Preferably the diaphragm by casket of the present invention has the pore-size that increases along from the outside direction of chamber interior.In this way, the good liquid conveying from the chamber interior to the test section especially can be combined with " not allowing microorganism and pathogen pass through " this aspect well.

The present invention thereby also relate to for a kind of ventilative and thoroughly application of diaphragm liquid, that the closure of openings of the chamber of pricker casket is got up is used for body fluid samples is flowed to test section on the opposite side of described diaphragm from the pricker on the side of described diaphragm.

The present invention also relates to a kind of system for the material concentration to be tested of body fluid samples is measured, this system has puncture instrument and the pricker casket that can be encased in the described puncture instrument, described pricker casket then has a housing and is enclosed in pricker in the chamber of sterilization, wherein each comprises at least one opening of chamber of a pricker with ventilative and saturating liquid, the diaphragm that is carrying the test section seals, and wherein said puncture instrument comprises a mechanism, be used for causing the puncture campaign of pricker, and after puncture the sample holding device of pricker is contacted with the described medial surface that is carrying the diaphragm of test section, so that the body fluid samples of being admitted by described sample holding device can move to place, described test section by capillary force.

As already mentioned, for pressing pricker casket of the present invention, each casket chamber that is comprising a pricker has at least two, preferred at least three openings, namely a puncture orifice, another opening and preferably also have an insert port, the sealing of wherein said puncture orifice is worn out by pricker when puncture, the diaphragm that the saturating liquid of described test section is being carried in wherein said another opening utilization seals, and the sealing of wherein said patchhole is punctured the driving mechanism of instrument and wears out, and is used for pricker is placed the puncture motion.Preferably this only described another opening seal with transparent diaphragm, all other chamber opening is then sealed with air-locked diaphragm seal.As diaphragm seal, especially can use metal forming and the metal forming of plastic foil, usefulness plastic coat.

Other details of the present invention and advantage are explained with reference to accompanying drawing by means of embodiment.Accompanying drawing illustrates as follows:

Fig. 1 is the embodiment by pricker casket of the present invention;

Fig. 2 is that the halfbody of casket shown in Figure 1 is together with the pricker that is arranged in wherein; And

Fig. 3 is pricker.

Fig. 1 shows a kind of pricker casket that has such as the plastic casing of being made by Merlon or polysulfones.In shown embodiment, described housing is combined by two and half housing 1a, 1b.Half following housing 1b is shown in Figure 2.Described housing 1 has a plurality of chambers, has arranged respectively a pricker 2 in these chambers.

A kind of embodiment of pricker 2 is shown in Figure 3.Described pricker 2 has sample holding device 3, and this sample holding device is configured to passage, is configured in other words rill of groove or rather in shown embodiment.In the time of in penetrating into patient's bodily tissue, described passage is full of the liquid of blood and/or interstice by capillary force.In order to enlarge the sample size of admitting, can be arranged side by side many passages.Described sample holding device 3 can have hydrophilic lining, such as heparin, admit for improvement of described sample.

The single chamber of described housing 1 preferably has respectively at least three openings, namely puncture orifice 4, insert port 5 and another opening 6, wherein pricker 2 stretches out from described puncture orifice when puncture, the push rod of instrument of wherein puncturing can be inserted in the described insert port 5, be used for pricker 2 from described puncture orifice 4 push away forward to puncture motion and again it being retracted and wherein said another opening 7 coverings in 6 tested districts.In Fig. 1, only show half of described another opening 6 in the mode that hides, in order to can find out better the structure of described pricker casket.

The diaphragm 8 of the saturating liquid of described opening 6 usefulness seals, and described test section 7 is on the described diaphragm.Described diaphragm 8 has the permeability limit less than 0.5 μ m, preferred 0.2 μ m.Those microgranules that surpass the described permeability limit aspect size are blocked by described diaphragm 8, and less microgranule can pass described diaphragm.The hole of described diaphragm 8 forms the passage that passes from described diaphragm 8.Relevant pore-size is the diameter of the maximum in its narrowest place of described passage at this.The relevant pore-size of described diaphragm preferably approximately is up to 5 μ m, preferably is up to 2 μ m.

Suitable diaphragm 8 is such as being made by fibrous material.Except paper, the material of especially being made by plastic optical fibre, especially adhesive-bonded fabric are suitable.In the situation of trade mark " TYVEC ", sell suitable adhesive-bonded fabric by E.I.Du Pont Company (DuPont), described adhesive-bonded fabric is made by the polyethylene fibre of welding.As the substitute of fibrous material, also can use other mushy material, such as foamed materials or the diaphragm made according to the inversion of phases method.Suitable diaphragm 8 is such as by German Dreieich(De Laiaixi) Pall Co., Ltd of Firma Pall GmbH(company) be called in name in the situation of BTS 45 and sell.Specially suitable is hydrophilic diaphragm.

Remaining chamber opening, namely puncture orifice 4 and insert port 5 in shown embodiment, itself equally can with saturating liquid and thus also ventilative diaphragm 8 seal.But preferred described opening 4, the material that 5 usefulness costs are more cheap, namely airtight thin film (not shown) seal.Especially plastic sheeting, metal forming and be suitable with the metal forming of plastic coat.

When making casket shown in Figure 1, at first described pricker 2 is arranged in the described casket chamber.Subsequently with described chamber opening 4,5 and 6 sealings.Then described pricker 2 is carried out disinfection, method is to pass will the sterilize gas of usefulness of described ventilative diaphragm 8 to join in the described casket chamber.Can in the water vapour of 121 ℃ heat, expose 20 minutes such as the casket of described sealing.In order to improve disinfective action, can sneak into the gas of other sterilization usefulness in the described water vapour.As the gas of sterilization usefulness, such as especially also using oxirane according to DIN/EN 550 or EN ISO 11135.

Described pricker 2 is in the described casket chamber barely, that is to say be included in described chamber in gas contact, and also contact with the gas that imports for carrying out disinfection thus.The needle point of described pricker 2 and the puncture zone 2a that is squeezed in patient's the body in when puncture that is connected on the needle point preferably do not contact with described casket housing 1, so that the whole surface of the regional 2a of described puncture contacts with gas in being included in described chamber, and also contact with the gas that imports for carrying out disinfection thus.The regional 2a of described puncture thereby especially can be rapidly be used for sterilization by gas.Described pricker 2 is such as can being maintained in the described casket chamber with the pricker body that is connected on the regional 2a of described puncture, and abuts on the casket wall body.

After sterilization, the test section 7 that will have for the testing reagent that body fluid samples is detected is applied to described ventilative diaphragm 8.Described testing reagent causes detection reaction existing in material to be tested, the situation such as glucose; By the material concentration to be tested that can determine the analysis of described material to be tested to look for.Preferred use following testing reagent, its detection reaction causes the change color of described test section, and described change color can be so that become possibility as the analysis of the photometric measurement for common the commercial calibration tape commonly used.

Described chamber opening 6 can be sealed with single diaphragm plate respectively.But simpler is with a unique diaphragm 8 a plurality of, preferred whole chamber opening 6 to be hidden.Can respectively single test section 7 be applied on the chamber opening 6 that is closed in the corresponding way.But simpler is will to cover in such as the carrier thin film that is made of transparent plastics with testing reagent, and put it on the diaphragm 8.If use impervious carrier thin film, be noted that then described reagent layer is towards the carrier thin film of described diaphragm 8.Preferably, described reagent layer abuts on the described diaphragm 8, that is to say with described diaphragm to contact, so that body fluid samples can be transferred to the described reagent layer from described diaphragm 8 well.

Described diaphragm ventilative and thoroughly liquid thus have towards described pricker 2, be used for admitting the downside of body fluid and being used for body fluid handed to the upper side that is in the test section on the described diaphragm 8 from sample holding device 3.Preferred described diaphragm has than pore-size high on described upper side at described downside.The pore-size of the raising on the described downside so that body fluid be easy to be transferred to the described diaphragm from pricker, the reduction on the described upper side pore-size then make the intrusion difficult of the pathogen of microorganism and other.

Transfer to described test section 7 in order to make sample pass described diaphragm 8 from the sample holding device 3 of pricker 2 well after pricker puncture, the reagent layer on the described carrier thin film should be configured to smoother.Especially less than 3 μ m, preferably the roughness value SQq less than 2 μ m is favourable.Less than 30 μ m, especially the roughness value SRmax less than 20 μ m is favourable.Indicated roughness value SRmax and SRq relate separately to and utilize according to DIN EN ISO 25178/(2 and 3) laser scanning microscope and the measurement of carrying out according to the image processing filter of the equivalence of ISO/DIS 16610-21.

Described pricker casket can be encased in the casket lattice of unshowned puncture instrument, and described casket lattice have the puncture driving device, is used for pricker 2 is released and again it retracted from described puncture orifice 4.Described puncture driving device can have a push rod for this reason, and this push rod is inserted in the insert port 5 of casket chamber when puncture, is coupled on the pricker 2 and with it and releases from described puncture orifice.At this, the thin film that not only described insert port 5 is closed but also the thin film that described puncture orifice 4 is closed all are pierced.For convenient described puncture driving device is coupled on the described pricker 2, this pricker can have coupling element, is perforation 2b in shown embodiment.Described puncture driving device so that the sample holding device 3 of pricker 2 when the thorn needle movement finishes, be resisted against on the described diaphragm 8.The body fluid samples of admitting is then admitted by described diaphragm 8 by capillary force, and passes this diaphragm and flow to described test section 7.Suitable puncture driving device can be such as realizing as the rotor drive with connecting rod controlling organization.In addition, described puncture instrument can have measuring device, and described measuring device can be with test section 7 such as determining concentration by photometric measurement.

Reference numerals list:

1 housing

1a half housing

1b half housing

2 prickers

2a punctures regional

The 2b perforation

3 sample holding devices

4 puncture orifice

5 insert ports

6 other openings

7 test sections

8 diaphragms.

Claims

1. pricker casket has a housing (1) and many and is enclosed in respectively pricker (2) in the chamber of sterilization of described housing (1), and wherein said chamber has respectively the puncture orifice (4) of utilizing thin film to seal,

It is characterized in that,

Described pricker (2) has for the sample holding device (3) of admitting body fluid, and

Described chamber has respectively another and utilizes ventilative and the saturating opening (6) that seals of diaphragm (8) of liquid, described diaphragm have towards described pricker (2), be used for admitting the downside of body fluid and the upper side that is used for body fluid is handed to the test section (7) that is arranged on the described diaphragm (8) from described sample holding device (3).

2. by one of aforementioned claim described pricker casket, it is characterized in that described diaphragm (8) is made by polymeric material.

3. by pricker casket claimed in claim 2, it is characterized in that described diaphragm (8) is made according to the inversion of phases method.

4. by each described pricker casket in the aforementioned claim, it is characterized in that described diaphragm (8) is hydrophilic.

5. by each described pricker casket in the aforementioned claim, it is characterized in that described diaphragm (8) has than hole large on upper side at downside.

6. by each described pricker casket in the aforementioned claim, it is characterized in that described ventilative diaphragm (8) is the plate that described a plurality of chamber opening (6) are covered in.

7. by each described pricker casket in the aforementioned claim, it is characterized in that the pricker needle point contacts with gas in being included in described chamber.

8. by each described pricker casket in the aforementioned claim, it is characterized in that described sample holding device (3) has passage.

9. by each described pricker casket in the aforementioned claim, it is characterized in that the testing reagent of described test section (7) contacts with described diaphragm (8).

10. by each described pricker casket in the aforementioned claim, it is characterized in that described test section (7) are configured on the carrier thin film, wherein said testing reagent is arranged between described carrier thin film and the described ventilative diaphragm (8).

11. by pricker casket claimed in claim 10, it is characterized in that described carrier thin film covers in a plurality of openings (6).

12. by each described pricker casket in the aforementioned claim, it is characterized in that described puncture orifice (4) is used air-locked membrane sealed.

13. the method for the manufacture of the pricker casket, wherein in the chamber of casket housing (1), arranged respectively a pricker (2) and subsequently with the sealing of described chamber, it is characterized in that, each at least one opening (4,5,6) that comprises the chamber of a pricker (2) utilizes ventilative diaphragm (8) to seal, and the gas of the usefulness of then will sterilizing passes described diaphragm (8) and joins in the described chamber, and method is that the described casket housing (1) that is closed is exposed in gas, preferred water steam and/or the oxirane of sterilization usefulness.

14. by the described method of claim 13, it is characterized in that, after sterilization, apply the test section (7) that has for the testing reagent that body fluid samples is detected at described diaphragm (8).

15. for the ventilative and thoroughly application of diaphragm (8) liquid, that the opening (6) of the chamber of pricker casket is closed, be used for body fluid samples is flowed to test section on the opposite side of described diaphragm from the pricker on the side of described diaphragm.